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GxP audits: How important are they and how are they conducted?

In the highly regulated pharmaceutical industry, audits are more than just a control mechanism – they are an indispensable tool for ensuring the quality and compliance of processes. Audits play a key role in ensuring that companies adhere to the strict requirements of Good Manufacturing Practice (GMP) and other GxP standards. The aim is not only to identify errors, but also to continuously improve processes and eliminate weaknesses before they lead to errors or quality problems. The role of audits in quality management can therefore not be overestimated. They help to meet regulatory requirements and at the same time strengthen the trust of customers and authorities in the company.

Below you will find out what a GxP audit is, why it is so important for companies in regulated industries and how it can be carried out optimally.

What is a GxP audit?

An audit is a systematic, independent and documented review that serves to determine whether activities and results meet the planned requirements. So much for the theory.

In the GxP area, audits are particularly important in practice, as they ensure that all processes actually meet the strict requirements of GMP, GLP and GCP standards. These audits not only check compliance with regulations, but also whether processes are used for continuous improvement and risk reduction and actually make this contribution.

Why are audits in the GxP area so important?

Audits fulfill a central function in the so-called Pharmaceutical Quality System (PQS) and offer many advantages that are important for the entire industry:

Audits guarantee that companies comply with and implement the legal and regulatory requirements in such a way that the medicines produced are of truly impeccable quality and also safe.
Audits make it possible to identify potential errors in operations and production at an early stage so that measures can be taken to minimize risks. This prevents critical errors or weaknesses in the production process from leading to serious problems and questionable medicines from reaching the market and patients.
Audits offer the opportunity to evaluate existing processes and identify optimization potential. In this way, companies can increase their efficiency and improve quality at the same time.
Regular audits strengthen the trust of customers, partners and regulatory authorities. A well-documented and executed audit shows that the company is able to critically scrutinize itself in order to reliably deliver high-quality products to the market.

The audit process: step by step

An audit in the GxP area follows a structured procedure that enables the auditor to thoroughly examine the processes in the company. Typically, an audit consists of six main phases:

Planning: Audit preparation is crucial for success. The parties involved must ensure that all relevant people and documents are available. Thorough planning ensures a smooth process.
The initial meeting: In this step, the auditors and the representatives of the company to be audited meet at the start of the audit. The audit plan or the audit agenda is discussed again. Questions are also clarified here and expectations are defined if they have not already been clearly understood before the audit.
Conducting the audit: The auditor checks the company’s premises, machines, documents and processes. Interviews with employees also take place during this phase in order to assess the practical implementation of the processes.
The final meeting: At the end of the audit, the results are summarized. This is where we discuss what worked well and where there is room for improvement.
The audit report: The auditor prepares a detailed report documenting the results of the audit. This report also contains recommendations to help the company eliminate weaknesses and further improve processes.
Follow-up of the audit results: After the audit, follow-up is essential to ensure that the recommended measures have been implemented. This includes documenting the corrections and, if necessary, rechecks to ensure the sustainability of the improvements.

Preparing the audited company for a GxP audit: how to succeed

Thorough preparation is the key to a successful audit. Companies should ensure that their documents are complete and up-to-date and that their employees are aware of the requirements of the audit. Employee training plays a central role here, as a well-prepared team helps to ensure that the audit runs smoothly and possible deficiencies can be identified at an early stage.

Tips for audit preparation:

Review all important documents, including SOPs (standard operating procedures), batch documentation and qualification documents
If possible, carry out internal mock audits in advance to identify weaknesses in advance
Bring your team up to speed on regulatory requirements and audit expectations

Successful audit practice: the key to success

A successful audit requires careful preparation, a clear structure and detailed follow-up. Cooperation between the auditor and the audited company is of great importance in order to develop a common understanding of the requirements and expectations. This not only promotes compliance, but also the continuous improvement of processes. Companies that integrate regular audits into their business processes improve their quality assurance and reduce the risk of production errors or non-compliance with regulations.

Conclusion: Audits as the key to quality assurance

Audits are an indispensable part of quality management in the GxP sector. They not only help to ensure compliance with regulations, but also promote the quality and safety of products. Thorough preparation and the selection of experienced auditors are crucial to the success of an audit.

At Experts Institut, we not only offer training courses for auditors, but are also happy to support you in ensuring your compliance and continuously improving your processes. We can do “audits”. Contact us at info@expertsinstitut.de

Would you like to find out more?

Listen to our podcast episode “Audits in the pharmaceutical industry”, in which we examine the importance and challenges of audits in detail: https://podcasters.spotify.com/pod/show/experts-insights/episodes/Audits-in-der-Pharmaindustrie-e2of577

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28. October 2024/by Dr. rer. nat. Dietmar Gross

Business Solutions

ISO 9001 certification: Step by step to a successful QMS

ISO 9001 certification is an internationally recognized standard in quality management. It stands for trust, efficiency and reliability – qualities that customers and business partners value. However, the certification process can seem challenging. In this guide, you will learn how to successfully implement certification and how we can support you step by step.

Why ISO 9001 certification?

ISO 9001 certification offers many advantages: more efficient processes, better risk management and greater trust from customers and partners. It can also open up new business opportunities, as many tenders and contracts require ISO certification.

1. initial consultation and analysis: the start

The first step towards ISO 9001 certification is a comprehensive analysis of your existing structures and processes. This will determine how well your quality management system (QMS) already meets the requirements of the standard and where improvements are needed.

Why is this important? Many companies already unconsciously fulfill parts of the ISO 9001 standards. A professional analysis uncovers these strengths and identifies specific weaknesses in order to make the process efficient and time-saving.

2. planning the implementation: tailored to your requirements

Following the analysis, a customized implementation plan is drawn up that defines all the steps required for full compliance with ISO 9001 standards.

What makes this step so important? Thoughtful planning ensures that the standard requirements are implemented without disrupting your day-to-day operations. This maximizes the benefits of certification and minimizes disruption.

3. implementation of the quality management system (QMS)

Now it is a matter of either implementing the QMS from scratch or optimizing existing processes. This ensures that all requirements of the ISO 9001 standard are met.

Why is this important? An optimized QMS not only improves the quality of your products and services, but also increases efficiency. Clear processes, reduced errors and motivated employees contribute to successful certification.

4. internal audits and training: Preparation is everything

Internal audits and the training of your employees are essential components before the official certification audit begins. They identify weak points and ensure that the QMS is implemented correctly. At the same time, employees are prepared for the new processes.

Why this step? Training ensures that employees understand the new processes and use the QMS efficiently. The internal audits ensure that your company is ready for official certification.

5th certification audit: The decisive step

During the certification audit, an external auditor checks whether your company meets the ISO 9001 requirements. This is the last step before receiving the certificate.

Our support: We accompany you through the entire audit process and are on hand to answer any questions or challenges you may have. Our aim is to make the audit as smooth as possible and ensure successful certification.

6. receipt of the certificate: Your seal of quality

After the successful audit, you will receive the ISO 9001 certificate, which is valid for three years and confirms that your company meets the highest quality standards.

What comes next? Regular internal audits and continuous improvements are crucial in order to maintain certification in the long term and to be successful in the recertification process.

Conclusion: Your partner for successful ISO 9001 certification

ISO 9001 certification requires careful planning and specialist knowledge. With our advice at your side, the process will be smooth and efficient. Contact us to find out more about our customized consulting services and make your certification a success. Get ahead and in touch with us – info@expertsinstitut.de

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25. September 2024/by Viola Cussmann

GMP, GXP

Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company’s staff can be huge, reflecting different cultures from around the world. This is one reason why many would assume that the entire world can be talked to, related to, and understood quite readily. It is part of everyday work for many after all-or so we think.

In the area of audits and inspections, crossing cultures happens all the time. Different cultures bring different perspectives, which can influence how audits are perceived and conducted. Where supply chains are globalized, trans-national and trans-continental audits and inspections are mandatory and pretty much normal in many company and regulatory settings. Understanding the nuances of each culture involved is essential for effective communication and successful outcomes.

True Multiculturalism and Cultural Limits

This poses a problem though: we learn to communicate, read, and perceive in our birth culture. And even if a society is highly diverse, we are still product of a cultural framework that is discrete-in other words, that has boundaries. It is simply impossible for one person to really become multicultural-ourlifespan is just not large enough. You may be the child of a double or third culture set of parents, but true multiculturalism in a single individual is virtually impossible.

So as we are controlled by our birth culture, we do not learn how to properly navigate in foreign cultural contexts (and globalization does not do away with this at all). We may think we know what is going on around us when we engage people from other host cultures, but we really do not. Even in a seasoned friendship with someone from another country, there will still be a vast degree of ignorance in understanding the other person. We believe we know and understand. But we miss most of it in reality. We continue to filter everything we experience, see, hear and judge through what we believe is normal, and our frame of reference is our birth culture. And we cannot stop doing it because we are not even aware of it.

The Impact of Culture on Audits and Inspections

And now it gets interesting: This problem includes audit and inspection situations!
Good auditing is more than knowing compliance requirements, audit methodology, and a work experience of 100+ or even 1000+ audits.

Culture is so powerful that it controls everything we think, say and do. And what we expect of others. In an audit situation (also in GMP inspections), this routinely produces misunderstandings. And many of them are never corrected, simply because neither the auditor nor the auditee is aware of them.

From document reviews, an auditor may conclude that a company is falsifying records, when the truth is though that what the auditor saw has nothing to do with cheating at all.

An auditor may think the auditee is trying to avoid saying the truth about a given audit question or subject, but there is no intent of this in the conversation at all. But the auditor is blind to this.

As a result of examples like these, auditors will put their impressions into the report, in a coded form of course, but it will color all parts of the report and the perception of GMP deficiencies-even the judgment on severeness.

If an auditor is not aware of what is missed and where the personal perception of things is going astray, then such an auditor must improve. The objectiveness of the report will suffer, and the picture that is brought home is greatly inaccurate. We do a disservice to the auditee and to our own sending unit. And frankly, to ourselves…

This plays out even more drastically in audits of suppliers or service providers where no GMP or GxP quality system is available. Such cultural ignorance can make or break the business relationship altogether.

How can you improve?

Stop thinking that cultural differences are easy to figure out. You cannot guess them. You need extra training for this.
Understand that cultural differences have little to do with differing food preferences or how a business card must be presented.
Respect that standards-even GMP-can be lived effectively in different ways.
Open to the truth that you do not know everything best.

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